BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOBEAM HOLMIUM LASER FIBERS

    MDR report key: 4360906 · Received December 19, 2014

    Report

    Report Number
    1018233-2014-00362
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Report Date
    December 1, 2014
    Manufacturer
    LASER PERIPHERALS LLC
    Product Code
    GEX
    PMA / PMN Number
    K120926
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END OF THE FIBER BROKE IN THE SCOPE. BREAK IS APPROXIMATELY 2 TO 4 CM FROM FIBER TIP. FIBER WAS BEING USED WITH A LUMIENS VERSA PULS SETTINGS WERE 4 AND 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837687 ENDOBEAM HOLMIUM LASER FIBERS GEX LASER PERIPHERALS LLC NA BMYEG009

    Patients

    Seq Age Sex Outcome Treatment
    1